System for improving cardiac function

ABSTRACT

A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S. patent application Ser. No.10/212,033, filed on Aug. 1, 2002, which is a continuation-in-part ofprior U.S. patent application Ser. No. 09/635,511, filed on Aug. 9,2000, now abandoned, which claims priority from U.S. Provisional PatentApplication No. 60/147,894, filed on Aug. 9, 1999, and are incorporatedherein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of this invention relate to a method and device forimproving cardiac function.

2. Discussion of Related Art

Congestive heart failure annually leads to millions of hospital visitsinternationally. Congestive heart failure is the description given to amyriad of symptoms that can be the result of the heart's inability tomeet the body's demand for blood flow. In certain pathologicalconditions, the ventricles of the heart become ineffective in pumpingthe blood, causing a back-up of pressure in the vascular system behindthe ventricle.

The reduced effectiveness of the heart is usually due an enlargement ofthe heart. A myocardial ischemia may, for example, cause a portion of amyocardium of the heart to lose its ability to contract. Prolongedischaemia can lead to infarction of a portion of the myocardium (heartmuscle) wherein the heart muscle dies and becomes scar tissue. Once thistissue dies it no longer functions as a muscle and cannot contribute tothe pumping action of the heart. When the heart tissue is no longerpumping effectively, that portion of the myocardium is said to behypokinetic, meaning that it is less contractile than the uncompromisedmyocardial tissue. As this situation worsens, the local area ofcompromised myocardium may in fact bulge out as the heart contracts,further decreasing the heart's ability to move blood forward. When localwall motion moves in this way, it is said to be dyskinetic, or akinetic.The dyskinetic portion of the myocardium may stretch and eventually forman aneurysmic bulge. Certain diseases may cause a global dilatedmyopathy, i.e., a general enlargement of the heart when this situationcontinues for an extended period of time.

As the heart begins to fail, distilling pressures increase, whichstretches the ventricular chamber prior to contraction and greatlyincreases the pressure in the heart. In response, the heart tissuereforms to accommodate the chronically increased filling pressures,further increasing the work that the now comprised myocardium mustperform.

This vicious cycle of cardiac failure results in the symptoms ofcongestive heart failure, such as shortness of breath on exertion, edemain the periphery, nocturnal dypsnia (a characteristic shortness ofbreath that occurs at night after going to bed), waking, and fatigue, toname a few. The enlargements increase stress on the myocardium. Thestress increase requires a larger amount of oxygen supply, which canresult in exhaustion of the myocardium leading to reduced cardiac outputof the heart.

SUMMARY OF THE INVENTION

The invention provides an apparatus for improving cardiac functioncomprising at least one external actuator, an elongate manipulatorconnected to the external actuator, a manipulator-side engagementcomponent on a distal end of the elongate manipulator, a collapsible andexpandable frame, a frame-side engagement component releasablyengageable with the manipulator side-engagement component so that theexternal actuator can steer the frame when collapsed into a ventricle ofa heart whereafter the frame is expanded, and at least one anchorconnected to the frame, movement of the external actuator allowing for(i) insertion of the anchor and (ii) a myocardium ventricle, (iii)subsequent withdrawal of the anchor of the myocardium, (iv) subsequentreinsertion of the anchor into the myocardium, said insertion securingthe frame to the myocardium in a selected position, and (v) subsequentdisengagement of the manipulator-side engagement component from theframe-side engagement component, said disengagement for releasing theframe from the elongate manipulator.

The frame may have a small cross-dimension when collapsed suitable forbeing inserted into the ventricle of the heart through a tubular passagein a large cross-dimension when expanded in the ventricle.

The frame may comprise plurality of segments extending from a centralportion of the frame.

The frame may be made of nickel titanium or stainless steel.

The apparatus may further comprise a membrane stretched between thesegments, the membrane dividing the ventricle into at least two volumes.The membrane may be made of ePTFE. The membrane may be a mesh.

The segments may further comprise first and second portions connected atends thereof such that the second portions are at an angle to the firstportions.

The frame may have proximal and distal sections. The frame may have adiameter of between 10 mm and 100 mm when expanded.

The apparatus may further comprise at least one active anchor and atleast one passive anchor. Said insertion of the passive anchor may be ina first direction and said withdrawal of the passive anchor may be in asecond direction, the second direction being substantially 180 degreesfrom the first direction.

The apparatus may further comprise a first passive anchor extending inthe first direction and a second passive anchor extending in a thirddirection. The active and passive anchors may have sharp ends thatpenetrate the myocardium.

The apparatus may further comprise a tubular passage with a distal endsuitable to be inserted into the ventricle.

The elongate manipulator may further comprise a frame member withproximal and distal ends and an anchor member with proximal and distalends, the frame and anchor members being moveable through the tubularpassage.

The manipulator side-engagement component may further comprise a frameformation on the distal end of the frame member and an anchoringformation on the distal end of the anchor member.

The apparatus may further comprise an external frame actuator connectedto the proximal end of the frame member and an external anchor actuatorconnected to the proximal end of the anchor member.

When the distal end of the elongate manipulator is in the selectedposition, a first movement of the external anchor actuator may cause theactive anchor to be inserted into the myocardium to secure the frame tothe myocardium and a second movement of the external anchor actuator maycause the active anchor to withdraw from the myocardium, said withdrawalreleasing the frame from the myocardium.

A first movement of the external frame actuator may cause the frameformation to engage the frame-side engagement component, said engagementsecuring the frame to the distal end of the elongate manipulator and asecond movement of the external frame actuator may cause the frameformation to disengage the frame-side engagement component, saiddisengagement releasing the frame from the elongate manipulator.

The frame may be shaped such that entry of the proximal section of theframe into the tubular passage causes the frame to partially collapsesuch that the passive anchor withdraws from the myocardium in the seconddirection and entry of the distal section of the frame into the tubularpassage causes the frame to collapse to the small cross-section so thatthe distal end of the elongate manipulator and the frame can be removedfrom the heart.

The elongate manipulator and the frame may be insertable into the heartsimultaneously and the frame may be shaped such that exposure of thedistal section of the frame from the distal end of the tubular passageallows the frame to partially expand and exposure of the proximalsection of the frame from the distal end of the tubular passage allowsthe frame to expand to a large cross-section, said expansion causing thepassive anchors to penetrate the myocardium to secure the frame to themyocardium.

The invention also provides an apparatus for improving cardiac functioncomprising a frame which includes a plurality of central segmentssurrounding a central axis, the central segments having first and secondends, the first ends being pivotally connected to one another, and aplurality of outer segments having first and second ends, the first endsbeing pivotally secured to the second ends of the central segments, amembrane secured to the frame such that movement of the second ends ofthe central segments away from the central axis causes the membrane tounfold, the unfolding of the membrane causing the outer segments topivot relative to the respective central segments away from the centralaxis and movement of the second ends of the central segments toward thecentral axis causes the membrane to fold, the folding of the membranecausing the outer segments to pivot relative to their respective centralsegments toward the central axis, and an anchor connected to the frame,the anchor being insertable into a myocardium of a heart to secure thecardiac device to the myocardium in a ventricle of the heart.

The frame may include at least three central segments and at least threeouter segments.

The membrane may be stretched between the central and the outersegments.

The anchor may be secured directly to the frame.

The invention further provides an apparatus for improving cardiacfunction comprising a frame, a membrane, having an inner surface,secured to the frame, the membrane and the frame jointly forming acardiac device being moveable between a collapsed and an expanded state,in a collapsed state at least a portion of the inner surface of themembrane facing a vertical axis of the cardiac device and the cardiacdevice being insertable into a ventricle of a heart, in the expandedstate the portion of the inner surface of the membrane facing away fromthe vertical axis and being in contact with a myocardium and the cardiacdevice being in a selected position in the ventricle, and an anchorconnected to the cardiac device, the anchor being insertable into themyocardium of the heart to secure the cardiac device to the myocardiumin the selected position in the ventricle.

The cardiac device may collapse toward the vertical axis and expand awayfrom the vertical axis.

The membrane may fold towards the vertical axis when the cardiac devicecollapses and may unfold away from the vertical axis when the cardiacdevice expands.

The frame may be at least one of nickel titanium and stainless steel.

The membrane may be made of ePTFE.

The anchor may have a sharp end.

The invention further provides an apparatus for improving cardiacfunction comprising a frame being expandable in a selected position to apre-set shape in a ventricle of a heart, a formation on the frame, andan anchoring device having an anchor, the anchoring device being engagedwith and rotatable relative the formation to rotate the anchor relativeto the frame, said rotation causing the anchor to be inserted into amyocardium of the heart, said insertion securing the frame in theselected position in the ventricle.

The anchoring device may engage the formation such that a first rotationof the anchoring device causes the anchor to move away from the frameand a second rotation of the anchoring device causes the anchor to movetoward the frame.

The formation may be a pin, and the anchor may be a screw.

The invention further provides an apparatus for improving cardiacfunction comprising at least a primary expandable frame being in aselected position in a ventricle of a heart when expanded, an anchorconnected to the frame, the anchor being insertable into a myocardium ofthe heart to secure the primary frame within the ventricle, a frame-sideengagement component connected to the primary frame, a membrane, and amembrane-side engagement component being engageable with the frame-sideengagement component, said engagement securing the membrane to theframe.

The apparatus may further comprise a secondary expandable frame being ina selected position in the ventricle of the heart when expanded, thesecondary frame being secured to the membrane and connected to themembrane-side engagement component thereby interconnecting the membraneto the membrane-side engagement component.

The anchor may be connected to the at least one frame.

The frame-side engagement component may be connected to the primaryframe at a central portion of the primary frame.

The membrane-side engagement component may be connected to the secondaryframe at a central portion of the secondary frame.

The apparatus may further comprise an active anchor being connected tothe frame-side engagement component such that a first movement of theframe-side engagement component causes the active anchor to enter themyocardium and a second movement of the frame-side engagement componentcauses the active anchor to withdraw from the myocardium.

The apparatus may further comprise a passive anchor being connected toat least one of the frames such that the passive anchor enters themyocardium when the frame expands.

The invention further provides an apparatus for improving cardiacfunction comprising a flexible liner, a membrane secured to the liner,the membrane and the liner jointly forming a cardiac device beingmoveable between a collapsed and an expanded state, in the collapsedstate the cardiac device being insertable into a ventricle of a heart.In the expanded state the cardiac device being in a selected position inthe ventricle, the liner covering a wall in the ventricle and themembrane separating the ventricle into two volumes, and an anchorconnected to the cardiac device, the anchor being insertable into amyocardium of the heart to secure the cardiac device to the myocardiumin the selected position in the ventricle.

The flexible liner may comprise a plurality of lengths of strands beingconnected at endpoints thereof.

The apparatus may further comprise a frame secured to the cardiac deviceand connected to the anchor thereby interconnecting the cardiac deviceand the anchor.

The apparatus may further comprise a frame-side engagement componentbeing connected to the cardiac device and an active anchor beingconnected to the frame-side engagement component such that a firstmovement of the frame-side engagement component causes the active anchorto enter the myocardium and a second movement of the frame-sideengagement component causes the active anchor to withdraw from themyocardium.

The apparatus may further comprise a passive anchor being connected tothe cardiac device such that the passive anchor enters the myocardiumwhen the cardiac device expands.

The invention further provides an apparatus for improving cardiacfunction comprising an expandable frame being in a selected position ina ventricle of the heart and having an outer edge when expanded, theouter edge defining a non-planar cross-section of an inner wall of aventricle and an anchor connected to the frame, the anchor beinginsertable into the myocardium of the heart to secure the frame to themyocardium in the selected position in the ventricle.

The apparatus may further comprise a membrane being secured to a frame,the membrane separating the ventricle into two volumes.

The frame may have a vertical axis and the outer edge may have adiameter, the diameter intersecting the vertical axis at an angle otherthan 90 degrees.

The invention further provides an apparatus for improving cardiacfunction comprising an anchor being insertable into a myocardium of aheart to secure the anchor to the myocardium within a ventricle of theheart, an anchor-side engagement component being secured to the anchor,an expandable frame being in a selected position in the ventricle whenexpanded, and a frame-side engagement component being secured to theframe, the frame-side engagement component being engageable with theanchor-side engagement component, said engagement securing the frame tothe anchor in the selected position in the ventricle.

The apparatus may further comprise a membrane being secured to theframe.

A first movement of the anchor-side engagement component may cause theanchor to enter a myocardium and a second movement of the anchor-sideengagement component may cause the anchor to withdraw from themyocardium.

A first movement of the frame-side engagement component may cause theframe-side engagement component to engage the anchor-side engagementcomponent and a second movement of the frame-side engagement componentmay cause the frame-side engagement component to disengage theanchor-side engagement component.

Said engagement may release the frame from the anchor.

The invention further provides an apparatus for improving cardiacfunction comprising a flexible body, a membrane connected to theflexible body, the membrane and flexible body jointly forming a cardiacdevice being movable between a collapsed and an expanded state, in thecollapsed state the cardiac device being insertable into a ventricle ofthe heart, in the expanded state the cardiac device being in a selectedposition in the ventricle, and an anchor connected to the cardiacdevice, the anchor being insertable into the myocardium of the heart tosecure the cardiac device to the myocardium in the selected position ofthe ventricle.

The apparatus may further comprise a frame having a distal end, themembrane may be secured to the frame, and the body may have proximal anddistal ends, the proximal end of the body being secured to the distalend of the frame, and the distal end of the body being connected to theanchor.

The body may be cylindrical with a diameter of between 0.5 mm and 6 mmand a height of between 1 mm and 100 mm.

The cardiac device may have a vertical axis.

The body may have a proximal opening at the proximal end, a distalopening at the distal end, and a passageway therethrough connecting theproximal and distal openings.

The body may be able to bend between 0 and 120 degrees from the verticalaxis.

The invention further provides a device for improving cardiac functioncomprising a collapsible and expandable frame having first and secondportions, the frame being insertable into a ventricle of a heart whencollapsed, when expanded the frame being in a selected position in theventricle and the second portion of the frame covering a wall in theventricle, a membrane secured to the frame such that the membranedivides the ventricle into at least two volumes when the frame isexpanded, the frame and the membrane jointly forming a cardiac device,and an anchor connected to the cardiac device, the anchor beinginsertable into a myocardium of the heart to secure the cardiac devicein the selected position in the ventricle.

The frame may further comprise a plurality of segments, each segmenthaving an inner and outer portion being connected at ends thereof, theouter portions being at an angle to the inner portions.

The membrane may be secured to the inner and outer portions of thesegments.

The device may further comprise a plurality of anchors being connectedto at least one segment such that when the frame expands the anchorsenter the myocardium in a first direction, and when the frame collapsesthe anchors withdraw from the myocardium in a second directionapproximately 180 degrees from the first direction.

Some of the anchors may extend in a third direction.

The invention further provides a system for improving cardiac functioncomprising a collapsible and expandable frame, when collapsed the framebeing insertable into a selected position in a ventricle of the heartthrough an opening in the heart having a small cross-dimension, whenexpanded in the selected position, the frame having a largecross-dimension, and an anchor connected to the frame, being insertableinto a myocardium of the heart to secure the frame to the myocardium inthe selected position.

The opening may be an incision in the myocardium.

The anchor may further comprise a plurality of strands woven through themyocardium such that the opening is closed.

The invention further provides a system for improving cardiac functioncomprising an external actuator, an elongate manipulator having a tubesuitable to be inserted into a ventricle of a heart to a selectedposition and a deployment member positioned therein slidable between afirst and second position, the deployment member having proximal anddistal ends, the distal end being within the tube when the deploymentmember is in the first position and out of the tube when the deploymentmember is in the second position, the deployment member being connectedto the external actuator at the proximal end thereof, a deployment-sideengagement component on the distal end of the deployment member, aframe-side engagement component being engageable with thedeployment-side engagement component, said engagement securing thedeployment-side engagement component to the frame-side engagementcomponent such that a movement of the external actuator causes theengagement components to disengage, said disengagement releasing thedeployment-side engagement component from the frame-side engagementcomponent, a frame being connected to the frame-side engagementcomponent, the frame being moveable between a collapsed and an expandedstate, the frame being connected to the deployment member in thecollapsed state with a small cross-dimension when the deployment memberis in the first position and the frame is within the tube, the framebeing shaped such that when the deployment member is moved to the secondposition and the frame exits the tube, the frame expands to the expandedstate with a large cross-dimension and when the deployment member ismoved back to the first position, the frame collapses to the collapsedstate as the frame enters the tube, and an anchor connected to the framebeing insertable into a myocardium of the heart to secure the frame tothe myocardium of the heart, such that the deployment mechanism can beremoved from the heart, the anchor entering the myocardium in a firstdirection when the frame expands and withdrawing from the myocardium ina second direction when the frame collapses, said withdrawal releasingthe frame from the myocardium.

The external manipulator may further comprise an anchor deployment knoband a detachment knob.

The deployment member may further comprise an anchor shaft havingproximal and distal ends and a detachment shaft having proximal anddistal ends, the proximal end of the anchor shaft being connected to theanchor deployment knob, the proximal end of the detachment shaft beingconnected to the detachment knob.

The deployment-side engagement component may further comprise adeployment-side anchor formation connected to the distal end of theanchor shaft and a deployment-side detachment formation connected to thedistal end of the detachment shaft.

The frame-side engagement component may further comprise a frame-sideanchor formation being connected to the anchor and a frame-sidedetachment formation on the frame, the frame-side anchor formation beingengageable with the deployment-side anchor formation, the frame-sidedetachment formation being engageable with the deployment-sidedetachment formation, a first movement of the detachment knob causingthe deployment-side detachment formation to engage the frame-sidedetachment formation, said engagement securing the frame to thedeployment member, a first movement of the anchor deployment knobcausing the anchor to enter the myocardium and a second movement of theanchor deployment knob causing the anchor to withdraw from themyocardium, a second movement of the detachment knob causing thedeployment-side detachment formation to disengage the frame-sidedetachment formation, said disengagement releasing the frame from thedeployment member.

The anchor shaft and the detachment shaft may be coaxial.

The anchor shaft may be an inner torque shaft and the detachment shaftmay be an outer torque shaft.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is further described by way of examples with reference tothe accompanying drawings, wherein:

FIG. 1 is an exploded side view of a system for improving cardiacfunction, according to one embodiment of the invention, including acardiac device and a deployment system, the deployment system includinga deployment mechanism and a catheter tube;

FIG. 2 is a cross-sectional side view of a handle of the deploymentmechanism and a proximal end of a deployment member of the deploymentmechanism;

FIG. 3A is cross-sectional side view of a distal end of the deploymentmember including a key and a detachment screw;

FIG. 3B is a cross-sectional end view on 3B-3B in FIG. 3A of thedeployment member;

FIG. 3C is a cross-sectional end view on 3C-3C in FIG. 3A of the key;

FIG. 4 is a perspective view of the cardiac device including a hub, aframe, and a stem thereof;

FIG. 5A is a side view of the cardiac device;

FIG. 5B is a perspective view of the hub;

FIG. 5C is a top plan view of the hub;

FIG. 6 is a cross-sectional side view of the stem;

FIG. 7A is a side view of the distal end of the deployment memberconnected to the cardiac device;

FIG. 7B is a cross-sectional view on 7B-7B in FIG. 7A of the cardiacdevice;

FIG. 8 is a cross-sectional side view of the cardiac device with the keyconnected thereto;

FIG. 9 is a side view of the system of FIG. 1 with the componentsintegrated with and connected to one another;

FIG. 10A is a view similar to FIG. 9 with the cardiac device partiallyretracted into the catheter;

FIG. 10B is a cross-sectional side view of a portion of FIG. 10A;

FIG. 11A is a side view of the system with the cardiac device furtherretracted;

FIG. 11B is a cross-sectional side view of a portion of FIG. 11A;

FIG. 12A is a side view of the system with the cardiac device fullyretracted;

FIG. 12B is a cross-sectional side view of a portion of FIG. 12A;

FIG. 13A is a cross-sectional side view of a human heart with thecatheter inserted therein;

FIGS. 13B-13K are cross-sectional side views of the human heartillustrating installation (FIGS. 13B-13E), removal (FIGS. 13E-13H), andsubsequent final installation (FIGS. 13I-13K) of the cardiac device;

FIG. 14A is a perspective view of a cardiac device according to anotherembodiment of the invention;

FIG. 14B is a cross-sectional side view of the human heart with thecardiac device of FIG. 14A installed;

FIG. 15A is a perspective view of a cardiac device according to afurther embodiment on the invention;

FIG. 15B is a cross-sectional top plan view of the cardiac device on15B-15B in FIG. 15A;

FIG. 15C is a cross-sectional side view of the human heart with thecardiac device of FIG. 15A installed;

FIG. 16A is a perspective view of a cardiac device according to afurther embodiment of the invention;

FIG. 16B is a cross-sectional side view of the cardiac device of FIG.16A;

FIG. 16C is a cross-sectional side view of the human heart with thecardiac device of FIG. 16A installed;

FIG. 17A is a perspective view of a cardiac device according to afurther embodiment of the invention;

FIG. 17B is a cross-sectional side view of the human heart with thecardiac device of FIG. 17A installed;

FIG. 18A is a perspective view of a cardiac device according to afurther embodiment of the invention;

FIG. 18B is a cross-sectional side view of the human heart with thecardiac device of FIG. 18A installed;

FIG. 19A is a perspective view of a cardiac device according to afurther embodiment of the invention;

FIG. 19B is a cross-sectional side view of the human heart while thecardiac device of FIG. 19A is being installed;

FIG. 19C is a cross-sectional side view of the human heart while thecardiac device of FIG. 19A is being installed;

FIG. 19D is a cross-sectional side view of a human heart with thecardiac device of FIG. 19A installed;

FIG. 20A is a perspective view of a frame of a cardiac device accordingto another embodiment of the invention;

FIG. 20B is a perspective view of a stem of the cardiac device of FIG.20A;

FIG. 20C is a cross-sectional side view of the cardiac device of FIG.20A and FIG. 20B with the stem attached to the frame;

FIG. 20D is a cross-sectional side view of a distal end of a deploymentmember of a deployment mechanism according to another embodiment of theinvention;

FIG. 20E is a cross-sectional side view of the distal end of thedeployment member of a deployment mechanism of FIG. 20D; and

FIGS. 20F-20I are cross sectional side views of a human heartillustrating installation of the cardiac device of FIG. 20A and FIG.20B.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a system 30 for improving cardiac function accordingto one embodiment of the invention. The system 30 includes a deploymentsystem 32 and a cardiac device 34. The deployment system 32 includes adeployment mechanism 36 and a catheter tube 38.

The catheter tube 38 is cylindrical with a length 40 of 110 cm and adiameter 42 of 5 mm. The catheter tube 38 has a circular cross-sectionand is made of a soft, flexible material.

The deployment mechanism 36 includes a handle 44 and a deployment member46. The handle 44 has a proximal end 48 and a distal end 50. Thedeployment member 46 has a proximal end 52 and a distal end 54. Theproximal end 52 of the deployment member 46 is secured to the distal end50 of the handle 44.

FIGS. 2, 3A, 3B, and 3C illustrate the deployment mechanism 36 in moredetail. FIG. 2 illustrates the handle 44 while FIGS. 3A, 3B, and 3Cillustrate components at the distal end 54 of the deployment member 46.The components of the deployment mechanism 36 are primarily circularwith center lines on a common axis.

The handle 44 is made of molded plastic and includes a main body 56, ananchor knob 58, an end piece 60, a proximal rotating hemostatic valve62, a fluid line 64, a distal rotating hemostatic valve 66, and adetachment knob 68. The main body 56 is cylindrical with a length 70 of80 mm and a diameter 72 of 25 mm. The main body 56 has a proximal 74 anda distal 76 opening at the respective ends thereof and a passageway 78therethrough connecting the openings with an inner diameter 80 of 4 mm.

The proximal rotating hemostatic valve 62 is a cylindrical body with apassageway 82 therethrough having an inner diameter 84 of 4 mm, alocking hypo tube 86 within the passageway, a tapered outer end 88, anda raised formation 90 at a central portion thereof. The proximalrotating hemostatic valve 62 is rotationally secured to the proximalopening 74 of the handle 44. The locking hypo tube 86 is a cylindricalbody secured within the passageway 82 of the proximal rotatinghemostatic valve 62.

The end piece 60 is a cylindrical body with a passageway 92 therethroughconnecting a proximal 94 and distal 96 opening at respective ends andhaving an inner diameter 98 of 5 mm. Raised formations 100 stand proudfrom respective central and outer portions of the end piece. Acylindrical end piece pin 102 is connected to an inner surface andextends across the inner diameter 98 of the passageway 92. The end piecepin 102 is made of stainless steel and has a length of 5 mm and adiameter of 2 mm. The distal opening 96 of the end piece 60 mates withthe tapered outer end 88 of the proximal rotating hemostatic valve 62.

The anchor knob 58 is a cap-shaped body with a length 104 of 20 mm andan outer diameter 106 of 10 mm. The anchor knob 58 has a small opening108 at a proximal end 110 with a diameter 112 of 4 mm and a largeopening 114 at a distal end 116 with a diameter 118 of 6 mm. The anchorknob 58 fits over and is secured to both the end piece 60 and theproximal rotating hemostatic valve 62.

The fluid line 64 enters the handle 44 through the small opening 108 ofthe anchor knob 58 and is secured to the proximal opening 94 of the endpiece 60. The fluid line 64 has an outer diameter 120 of 5 mm.

The distal rotating hemostatic valve 66 is a cylindrical body with apassageway 122 therethrough having a proximal inner diameter 124 of 4 mmat a proximal end 126 thereof and a distal inner diameter 128 of 5 mm ata distal end 130 thereof. The distal end 130 is tapered, and a raisedformation 132 lies at a central portion thereof. The distal rotatinghemostatic valve 66 is rotationally secured to the distal opening 76 ofthe main body 56.

The detachment knob 68 is a cap-shaped body with a length 134 of 20 mmand an outer diameter 136 of 20 mm. The detachment knob 68 has a largeopening 138 at a proximal end 140 with a diameter 142 of 8 mm and asmall opening 144 at a distal end 146 with a diameter 148 of 5 mm. Thedetachment knob 68 fits over and is secured to the distal rotatinghemostatic valve 66.

Referring to FIGS. 3A-3C, the deployment member 46 includes an innertorque shaft 150 and an outer torque shaft 152. The inner torque shafthas a diameter 154 of 2 mm and is made of surgical stainless steel. Theouter torque shaft is a hollow, cylindrical body with an inner diameter156 of 3 mm and an outer diameter 158 of 5 mm. The outer torque shaft152 is a polymer.

Referring again to FIG. 2, the inner torque shaft 150 passes through thedetachment knob 68, through the distal rotating hemostatic valve 66,into and out of the passageway 78 of the main body 56, through theproximal rotating hemostatic valve 62, and into the end piece 60. Theproximal end of the inner torque shaft 150 is wrapped around the endpiece pin 102, reenters the proximal rotating hemostatic valve 62, andis attached to the locking hypo tube 86 within the proximal rotatinghemostatic valve 62.

The outer torque shaft 152 is coaxial with and surrounds the innertorque shaft 150. A proximal end 160 of the outer torque shaft 152passes into the distal hemostatic valve 66 and is secured thereto.

The distal end 54 of the deployment member 46 includes a key 162, adetachment screw 164, and a securing mechanism 166. A distal end 168 ofthe inner torque shaft 150 extends out of a distal end 170 of the outertorque shaft 152, and the key 162 is attached thereto. The key 162 isrectangular with a length 171 of 7 mm and a height 172 of 3 mm. The key162 has a semi-circular cross section with a radius 174 of 1.5 mm. Thedetachment screw 164 is attached to the distal end 170 of the outertorque shaft 152, extends to a length 176 of 7 mm, and has a diameter178 of 5 mm.

The securing mechanism 166 includes an inner component 180 and an outercomponent 182. The inner component 180 is a raised cylindrical portioncoaxial with and on the inner torque shaft 150. The inner component 180stands proud of the inner toque shaft 150 by 0.5 mm. The outer component182 is a hollow, cylindrical body secured to an inner surface of theouter torque shaft 152 and has proximal and distal openings withdiameters of 2.25 mm so that the inner toque shaft 150 cannot moveaxially relative to the outer torque shaft 152.

FIGS. 4, 5A-5C, and 6 illustrate the cardiac device 34 in more detail.The cardiac device 34 includes a frame 184 and a stem 186, or flexiblebody, and has a vertical axis 188.

The frame 184 includes a frame hub 190, a plurality of main segments192, and a membrane 194. The hub 190 is a ring-shaped body with an outersurface 196 with a diameter 198 of 5 mm, an inner surface 200 with adiameter 202 of 4 mm, a thickness 204 of 3 mm, and a pin 206 extendingoff-center across the inner surface 200 creating a smaller and a largergap. The pin 206 has a length of 3.5 mm and a diameter of 1 mm and islocated in a plane 208. The frame 184 has a diameter 209 ofapproximately 25 mm, however, other embodiments may have diameters ofbetween 10 mm and 100 mm. The entire hub 190 is made of nickel titanium.

The main segments 192 include first portions, or central segments, 210,second portions, or outer segments, 212, and passive anchors 214. Thefirst portions 210 are connected to the hub 190 at a central portion ofthe outer surface 196 and extend radially from the hub 190 at an angleaway from the plane 208 of the pin 206 to a length 216 of 8 mm. Thesecond portions 212 of the segments 192 are connected to ends of thefirst portions 210 and further extend radially from the hub 190 but atan angle towards the plane 208. The second portions 212 each have alength 218 of 5 mm. The passive anchors 214 are formed at an end of eachof the second portions 212. The passive anchors 214 have sharp ends thatpoint slightly radially from the hub 190. The segments 192 are made fromnickel titanium, which after a prescribed thermal process, allows forthe segments 192 to hold their shape as illustrated, for example, inFIG. 4. The entire frame 184, or just portions of the frame 184, mayalso be made of stainless steel.

The membrane 194 is stretched over the first 210 and second 212 portionsof the segments 192 to give the frame 184 a disk like shape. Themembrane 194 is made of expanded Poly Tetra Fuoro Ethylene (ePTFE) andhas a thickness of 0.08 mm. Other embodiments may use a mesh membrane.

FIG. 6 illustrates the stem 186 unattached to the frame 184. The stem186 is a hollow, cylindrical body with a passageway 220 therethoughconnecting a proximal 222 and a distal 224 opening. The stem 186 has aheight 226 of 9 mm, an outer diameter 228 of 5 mm, and an inner diameter230 of 4 mm. The stem 186 includes a first hub 232 and a second hub 234,both similar to the hub 190 on the frame 184. The second hub 234 issecured within the passageway 220 near the distal opening 224 of thestem 186. The first hub 232 is loose within the stem 186 so that it maymove, and has an active anchor 236, in the shape of a screw, attached.The active anchor 236 spirals from the first hub 232 to engage with thepin on the second hub 234. The active anchor 236 has a diameter 238 of3.5 mm and a length 240 of 7 mm.

The stem 186 is made of Poly Tetra Fuoro Ethylene (PTFE) and is thusexpandable and flexible. Referring again to FIG. 4, the stem 186 can becompressed or stretched by 30% of its length and can be bent from thevertical axis 188 of the device 34 by 120 degrees in any direction. Thefirst hub 232, second hub 234, and active anchor 236 are made of nickeltitanium. In other embodiments, the hubs may be made of stainless steel.

FIGS. 7A, 7B, 8, and 9 illustrate the system 30 with the stem 186connected to the cardiac device 34 and the cardiac device 34 connectedto the deployment mechanism 36. The stem 186 is fused to the frame hub190 thus securing the stem 186 to the device 34.

In use, the deployment member 46 is inserted through the catheter tube38 so that the distal end 54 of the deployment member 46 exits thedistal end of the tube 38. As shown is FIGS. 7A and 7B, the deploymentmember 46 connects to the cardiac device 34 such that the key 162engages the hub 190 of the frame 184 by passing through the larger gapin the hub 190. As shown in FIG. 8, the key 162 passes through the hub190 of the frame 184 to engage with the first hub 232 of the stem 186,but does not reach the second hub 234. Once the key 162 is fullyinserted into the stem 186, the detachment knob 68 is turned whichrotates the outer torque shaft 152 and thus the detachment screw 164because the detachment screw 164 is attached to the outer torque shaft152. The rotation thereof causes the detachment screw 164 to engage withthe pin 206 of the frame hub 190, securing the cardiac device 34 to thedeployment mechanism 36.

Rotation of the anchor knob 58 in a first direction causes the activeanchor 236 to be deployed from the distal opening 224 of the stem 186because the anchor knob 58 is connected to the inner torque shaft 150which, in turn, is connected to the key 162. Rotation of the key 162causes the first hub 232 to rotate and because the active anchor 236 isconnected to the first hub 232 and engaged with the pin of the secondhub 234, the active anchor 236 “twists” out of the distal opening 224 ofthe stem while the first hub 232 is pulled toward the distal opening224. Rotation of the anchor knob 58 in a second direction causes theactive anchor 236 to reenter the distal opening 224 of the stem 186.

As illustrated in FIGS. 10A and 10B, the distal end 54 of the deploymentmember 46 is then pulled into the distal end of the catheter tube 38. Asa proximal section of the frame 184 enters the catheter tube 38, thefirst portions 210 of the segments 192 begin to collapse towards thestem 186. The segments 192 collapse, or fold, against a spring forcethat is created by the resilient nature of the nickel titanium materialfrom which they are made. At the same time, the second portions 212 fanout radially away from the hub 190.

As illustrated in FIGS. 11A and 11B, by the time a distal section of theframe 184 and the second portions 212 of the segments 192 begin to enterthe tube 38, the second portions 212 have been bent back to collapsetowards the stem 186 similarly to the first portions 210.

FIGS. 12A and 12B illustrate the system 30 with the cardiac device 34completely contained within the catheter tube 38.

FIGS. 13A-13J illustrate a human heart 242 while the cardiac device 34is being deployed. The heart 242 contains a right ventricle 244 and aleft ventricle 246 with papillary muscles 248 and an akinetic portion250 with an apex 252. The distal end of the catheter 38 has beeninserted through the aorta and aortic valve into the left ventricle 246to a selected position where the cardiac device 34 can be deployed. Thecatheter tube 38 is then partially pulled off of the cardiac device 34exposing the stem 186.

The active anchor 236 is then deployed by rotating the anchor knob 58 ina first direction. The active anchor 236 penetrates the myocardium ofthe heart 242 to secure the cardiac device 34 in the selected positionat the apex 252 of the akinetic portion 250 of the left ventricle 246.

The catheter 38 is then completely removed from the distal end 54 of thedeployment member 46, exposing the cardiac device 34. As the cardiacdevice 34 expands, due to the resilient nature of the segments 192 andthe preset shape of the frame 184, the passive anchors 214 on thesegments 192 penetrate the myocardium in a first direction. The membrane194 seals a portion of the ventricle 246 and separates the ventricle 246into two volumes, a functional portion 249 and a non-functional portion251.

If the cardiac device 34 has not been properly positioned, or if it isof the wrong size or shape for the particular heart, the device 34 maybe repositioned or completely removed from the heart 242.

Rotation of the anchor knob 58 in a second direction will cause theactive anchor 236 to be removed from the apex 252 of the akineticportion 250 of the left ventricle 246 thus releasing the cardiac device34 from the heart 242. The distal end 54 of the deployment member 46 maybe retracted into the catheter 38 to once again fold the cardiac device34 into the position shown in FIG. 12B, from where it can again bedeployed. The passive anchors 214 are removed from the myocardium in asecond direction which is approximately 180 degrees from the firstdirection so that minimal damage is done to the myocardium.

However, if the cardiac device 34 has been properly positioned and is ofthe proper size and shape, rotation of the detachment knob 68 in asecond direction will cause the detachment screw 164 at the distal end170 of the outer torque shaft 152 to disengage the pin 206 in the framehub 190, thus releasing the deployment member 46 from the cardiac device34 to allow removal of the deployment member 46 from the heart 242. FIG.13K illustrates the heart 242 with the cardiac device 34 installed andthe deployment mechanism 36 removed from the heart 242.

One advantage of this system is that the shape of the frame 184 allowsthe device 34 to be retrieved as long as the deployment member 46 isstill connected to the device 34. When the device 34 is retrieved, thepassive anchors 214 withdraw from the myocardium in a direction that isapproximately 180 degrees from, or opposite, the first direction tominimize the amount of damage done to the myocardium. The device 34 alsoprovides support for the akinetic region 250, minimizes the bulging ofthe akinetic region 250, and reduces stress on the working parts of themyocardium. A further advantage is that the ePTFE membrane 194 isbiocompatible, has a non-thrombogenic surface, promotes healing, andaccelerates endothelization.

FIG. 14A illustrates a cardiac device 254 according to anotherembodiment of the invention. The cardiac device includes a hub 256, aframe 258, and a membrane 260. The hub 256 lies at a central portion ofthe frame 258 and an active anchor 262 is connected to the hub 256 andextends downwards therefrom. The frame 258 includes a plurality ofsegments 264 which extend radially and upwardly from the hub 256. Asharp passive anchor 266 lies at the end of each of the segments 264.The membrane 260 is stretched between the segments 264 to form acone-shaped body.

FIG. 14B illustrates a human heart with the cardiac device 254 of FIG.14A having been secured to an akinetic portion thereof to partition theheart chamber into to separate portions, a functional portion 267 and anon-functional portion 269.

FIG. 15A and FIG. 15B illustrate a cardiac device 268 according to afurther embodiment of the invention. The cardiac device includes a hub270, a frame 272, and membrane 274. The hub 270 lies at a centralportion of the frame 272 and an active anchor 276 extends downwardlyfrom the hub 270. The frame 272 includes a plurality of segments 278which extend radially and upwardly from the hub 270. The segments 278are of different lengths such that an outer edge 280 of the cardiacdevice 268 is not planar. The device 268 has a vertical axis 282 whichintersects a diameter 284 across the outer edge 280 of the device 268 atan angle other than 90 degrees. A sharp passive anchor 286 lies at theend of each of the segments 278. The membrane 274 is stretched betweenthe segments 278 to form a cone-shaped body. Referring specifically toFIG. 15B, a cross-section perpendicular to the vertical axis 282 of thedevice 268 is circular.

FIG. 15C illustrates a human heart with the cardiac device 268 of FIG.15C having been secured to an akinetic portion thereof to partition theheart chamber into a functional portion 279 and a non-functional portion281.

A further advantage of this embodiment is that the device 268 can besized and shaped for use on a wider variety of akinetic portions in leftventricles.

FIG. 16A and FIG. 16B illustrate a cardiac device 288 according to afurther embodiment of the invention. The cardiac device 288 includes afirst hub 290, a first frame 292, a second hub 294, a second frame 296,a first membrane 298, and a second membrane 300. The first hub 290 isattached to a central portion of the first frame 292. A plurality ofsegments 302 extend radially from and upwards from the first hub 290.The first membrane 298 is occlusive and made of a thrombogenic materialand stretched between the segments 302 to form a first cone-shaped body.A plurality of fibers 304 extend radially from an outer edge 306 of thefirst cone-shaped body. An active anchor 308 extends down from the firsthub 290.

The second frame 296 includes a plurality of segments 310 extendingradially and upwardly from the second hub 294 and end in sharp passiveanchors 312. An attachment screw 314, similar to the detachment screw164, extends downwards from the second hub 294. Referring specificallyto FIG. 16B, the attachment screw 314 is rotated so that it engages apin 316 within the first hub 290, similarly to the frame hub 190 alreadydescribed, to secure the second frame 296 to the first frame 292. Thesecond membrane 300 is made of ePTFE and stretched between the segments310 to form a second cone-shaped body.

FIG. 16C illustrates a human heart with the cardiac device 288 of FIG.16A secured to an akinetic portion thereof. The fibers 304 on the outeredge 306 of the first frame 292 are interacting with an inner surface ofthe left ventricle to seal off the volume below the outer edge 306 ofthe first frame 292. The passive anchors 312 on the ends of the segments310 of the second frame 296 have penetrated the myocardium to hold thedevice 288 in place.

A further advantage of this embodiment is that the fibers 304 of thefirst membrane 298 interface with trabeculae and further block the flowof blood into the apex of the akinetic portion.

FIG. 17A illustrates a cardiac device 318 according to a furtherembodiment of the invention. The cardiac device 318 includes proximal320 and distal 322 hubs, a frame 324, a stem 326, a braided structure328, and a membrane 330. The frame 324 includes a plurality of segments332 extending radially and upwards from the distal hub 322, and themembrane 330 is stretched between the segments 332 to form a cone-likebody having an outer edge 334. Two extra segments 336 extend across theouter edge 334 of the cone-like body and are connected to and supportthe proximal hub 320 above the distal hub 322. The stem 326, includingan active anchor 338, extends downwards from the distal hub 322. Thebraided structure 328 is made of nickel titanium and is connected to adistal end of the stem 326 into the ends of the segments 332. Thesegments 332 end in sharp passive anchors 340. The braided structure 328may also be made of a biodegradable material or a polymer.

FIG. 17B illustrates a human heart with the cardiac device 318 of FIG.17A having been secured to an akinetic portion thereof. The braidedstructure 328 presses against an inner surface of the left ventricle.

A further advantage of this embodiment is that the braided structure 328allows the device to “nestle” into position before the active anchor 338is deployed to secure the device 318 in place. Further advantages arethat the braided structure 328 adds structural stability to the device318 and the nickel titanium of the braided structure 328 provides amechanism for containing thrombi in the static chamber.

FIG. 18A illustrates a cardiac device 342 according to a furtherembodiment of the invention. The cardiac device 342 includes proximal344 and distal 346 hubs, a frame 348, and a membrane 350. A pluralitysegments 352, having first 354 and second 356 portions, extend upwardlyand radially from the distal hub 346 in a curved fashion and are bentand extend inwards to meet at the proximal hub 344. The membrane 350 isstretched across the segments 352 to form a semi-circular orbasket-shaped body. Sharp passive anchors 358 extend from the segments352 between the first 354 and second 356 portions.

Some of the passive anchors 358 extend in a primarily axial directionwith a small radial component, and some of the passive anchors 358extend in a primarily radial direction with a small axial component.Other embodiments may have both types of passive anchors on a singlesegment.

FIG. 18B illustrates a human heart with the cardiac device 342 of FIG.18A having been installed into an akinetic portion thereof. The segments352 are pressed against the myocardium because the device is slightlyoversized.

A further advantage of this embodiment is that because of the size ofthe device 342 and shape of the segments 352, the passive anchors 358are assisted in penetrating the myocardium. A further advantage is thatbecause of the shape of the frame 348, the device 342 can be retrievedfrom the left ventricle as long as the device 34 is still attached tothe deployment member 46. A further advantage is that because the entireframe 348 is covered with the membrane 350, the flow of blood to theapex of the akinetic portion is even further blocked.

FIG. 19A illustrates a cardiac device 360 according to a furtherembodiment of the invention. The cardiac device 360 includes a frame 362and a stem 364. The frame 362 includes a plurality of segments 366 whichextend upwardly and radially from the stem 364 and end in a plurality ofsharp passive anchors 368. The stem 364 extends downwards from the frame362 and includes two suture strands 370 at a distal end thereof.

FIGS. 19B, 19C, and 19D illustrate the installation of the cardiacdevice 360 of FIG. 16. While a high pressure is maintained in the leftventricle the catheter tube 38 is inserted through the outer wall intothe left ventricle with the cardiac device 360 inserted in the distalend thereof. The catheter 38 is removed from the cardiac device 360, andthe cardiac device 360 expands such that the passive anchors 368 areinserted into the inner surface of the left ventricle. The catheter 38is then completely removed and the sutures 370 are used to close theinsertion made by the catheter 38 and to secure the cardiac device 360to the akinetic portion.

FIGS. 20A, 20B, and 20C illustrate a cardiac device 372 according to afurther embodiment of the invention. The cardiac device 372 includes aframe hub 374, a frame 376, a membrane 378, and a stem 380. The framehub 374 lies at a central portion of the frame 376. The frame 376includes a plurality of segments 382 which extend radially and upwardlyfrom the frame hub 374. A sharp passive anchor 384 lies at the end ofeach of the segments 382. The membrane 378 is stretched between thesegments 382 to form a cone-shaped body. Before installation, the stem380 is unattached to the frame hub 374 and includes a proximal hub 386,an anchor hub 388, and a distal hub 390, each having a pin 392 extendingacross an inner surface thereof, similar to that of the frame hub 190.The proximal 386 and distal 390 hubs are frictionally held near theirrespective ends in the stem 380, and the anchor hub 388 is loose withinthe stem 380 so that it may move. An active anchor 394 extends downwardsfrom the anchor hub 388.

FIGS. 20D and 20E illustrate another embodiment of a distal end 396 of adeployment member 398. The distal end 396 includes a detachment piece400 and an attachment hub 402. The detachment piece 400 has been addedto the distal end of the outer torque shaft 152. The detachment piece400 is a ring shaped body made of stainless steel with a length of 3 mmand an inner diameter suitable to frictionally hold the attachment hub402, which is similar to the frame hub 190. An attachment screw 404,similar to the detachment screw 164, extends downwards from theattachment hub 402. Referring specifically to FIG. 20E, forces along thelength of the deployment member 398 will, by design, cause theattachment hub 402 to become dislodged from the detachment piece 400.

FIGS. 20F-20H illustrate installation of the cardiac device 372 of FIGS.20A and 20B into a human heart. In this embodiment, the deploymentmember used does not include the securing mechanism 166 so that theinner and outer torque shafts may move axially relative to one another.

Before the device 372 and stem 380 are inserted into a heart, the innertorque shaft is passed through the frame hub 374, the proximal hub 386,and the anchor hub 388, and the outer torque shaft is positioned androtated so that the attachment screw 404 engages both the pins 392 ofthe frame 374 and proximal 386 hubs, securing the cardiac device 372 tothe stem 380. The device 372 and the stem 380 are then retracted intothe catheter 38 and steered into a left ventricle. The stem 380 issecured to an apex of an akinetic portion of a left ventricle of theheart by rotating the inner torque shaft, causing the active anchor 394to penetrate the myocardium. Rotation of the outer torque shaft thencauses the attachment screw 404 to disengage the pin 392 of the proximalhub 386, and the device 372 is released from the stem 380. However, theinner torque shaft remains engaged with the hubs in the stem 380.

If it is determined that the stem 380 has been properly positioned, thecardiac device 372, secured to the outer torque shaft, is pushed overthe inner torque shaft to meet the stem 380. The outer torque shaft isagain rotated so that the attachment screw 404 reengages the pin 392 onthe proximal hub 386 of the stem, thus re-securing the stem 380 to theframe 376. The deployment member 398 is then forcibly pulled away fromthe device 372 and the detachment piece 400 releases the attachmentscrew 404. FIG. 201 illustrates the human heart with the cardiac device372 of FIGS. 20A and 20B installed.

While certain exemplary embodiments have been described and shown in theaccompanying drawings, it is to be understood that such embodiments aremerely illustrative and not restrictive of the current invention, andthat this invention is not restricted to the specific constructions andarrangements shown and described since modifications may occur to thoseordinarily skilled in the art.

1. A device for improving a patient's cardiac function, comprising: a. acollapsible and expandable frame having first and second portions, theframe being insertable into a ventricle of the patient's heart whencollapsed, when expanded to a diameter equal or greater than 35 mm andless than or equal to 100 mm the frame being in a selected position inthe ventricle and the second portion of the frame covering a wall in theventricle; b. a membrane secured to the frame such that the membranedivides the ventricle into at least a main productive portion and anon-productive portion when the frame is expanded, the frame and themembrane jointly forming a cardiac device; and c. an anchor connected tothe cardiac device, the anchor being insertable into the patient's hearttissue to secure the cardiac device in the selected position in theventricle, wherein all portions of the frame secured to the membrane,when expanded, are at a minimum angle of 10° to 45° with respect to alongitudinal axis of the anchor.